Triamcinolone Acetonide Injections in Mild-to-moderate Chronic Plaque Psoriasis With a Novel Needle-free Drug-delivery System

University Hospitals (UH)

Status and phase: Completed; Early Phase 1

Conditions: Psoriasis

Treatments: Device: Med-Jet; Other: Traditional Syringe

Study type: Interventional

Funder types: Other

Identifiers

NCT04410237

STUDY20200508

Details and patient eligibility

About

This is an observational pilot study comparing triamcinolone acetonide injections with the investigational Med-jet needle-free drug-delivery system as an alternative to using a conventional syringe and needle in patients with mild-to-moderate psoriasis. There will be five (5) visits necessary for study participation. The hypothesis is that the efficacy, safety, pain tolerance, and quality of life (QoL) metrics of the Med-jet needle-free drug-delivery system will be equal to or superior to that of a conventional syringe and needle.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with plaque-type psoriasis defined by either:

  • A board-certified dermatologist, OR
  • Dermatology Nurse Practitioner, OR
  • Skin punch biopsy

• Involvement of body surface area (BSA) < 10% at screening and baseline visit.

• The presence of plaque-type psoriasis at least two (2) plaques that are at least two (2) cm² in areas of the trunk, buttock, or extremities that are either:

  • Symmetrically located on contralateral body site OR
  • Within the same body site but separated by ≥ 1 cm

• Able to give informed consent under IRB approval procedures

Exclusion criteria

• Known allergy or hypersensitivity to triamcinolone acetonide
• Pregnant, breastfeeding, or planning to get pregnant 4 weeks before, during, and 4 weeks after the study.
• Inability to provide informed consent
• Active untreated diseases or medication usage which may interfere with wound healing and immune function (anti-neoplastic, systemic immunosuppressants, anticoagulants, daily NSAIDS)
• Use of tanning booths for at least 4 weeks prior to baseline visit
• Current or recent use of topical steroid, tar, phototherapy, Vitamin D, or retinoid therapy to target lesions for at least 2 weeks prior to baseline visit
• Current or recent use of systemic or biologic therapy for at least 4 weeks or 5 half-lives of the drug (whichever is longer) prior to baseline visit

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Med-Jet

Experimental group

Description:

The Med-Jet injector is a novel needle-free drug-delivery system, which we believe may be a solution to the impracticalities of ILTA for mild-to-moderate psoriasis. It uses regulated compressed air as a power source to accelerate an injectable fluid through a 0.005" orifice (6x smaller than a 30G needle) to penetrate the skin and deliver medication to a specific anatomical region.12 The drug-delivery device is highly configurable allowing adjustable depth and volume parameters.12 In addition, the high-performance design allows for triggering multiple injection sites rapidly which is practical when needing to treat large surface areas

Treatment:

Device: Med-Jet

Traditional Syringe

Active Comparator group

Description:

TAC will be injected on a half-plaque while the control half of the plaque will be untreated. A standard sterile disposable 1 ml syringe and 30-gauge needle will be used to inject TAC.

Treatment:

Other: Traditional Syringe